CARDIOVASCULAR JOURNAL OF AFRICA • Vol 22, No 5, September/October 2011
AFRICA
279
Industry News
Medtronic news from European Society of Cardiology congress,
Paris, September 2011
Medtronic announces approval for their larger transcatheter aortic valve in Europe
Medtronic Inc. has received CE
(Conformite Europeenne) Mark for its
31-mm Medtronic CoreValve
®
System,
the only transcatheter aortic valve avail-
able in the world that can treat without
surgery, patients with larger valve open-
ings (up to 29 mm). It is the largest tran-
scatheter valve available and, because it
can be compressed into a small delivery
system, is deployed through the same
18-Fr (less than ¼ inch or approx 6 mm
in diameter) delivery system as smaller
CoreValve sizes.
Medtronic’s CoreValve portfolio now
includes 26-, 29- and 31-mm valves – all
based on the self-expanding platform that
received CE Mark in 2007. Individual
sizing is critical to achieving optimal
patient blood flow (haemodynamic
function) and reducing adverse events,
making the availability of an additional
size an important offering to physicians
and patients. The Medtronic CoreValve
System is currently limited to investiga-
tional use in the USA.
‘The 31-mm CoreValve size allows us
to provide a lifesaving treatment option for
more patients with severe aortic stenosis’,
said Prof Ulrich Schafer, MD PhD, from
Aslepior Klinik St Gorge Hamburg. ‘We
have seen positive clinical outcomes with
the CoreValve System and are pleased to
offer it to individuals who, until now, have
been denied transcatheter aortic valve
implantation due to their larger native
valve size.’
The CoreValve System is designed to
provide a minimally invasive treatment
option without open-heart surgery for
patients with symptomatic, severe aortic
stenosis who are at high risk, or are ineli-
gible for open-heart surgery. Worldwide,
approximately 300 000 people have
been diagnosed with this condition, and
approximately one-third of these patients
are deemed too high a risk for open-
heart surgery. Since 2007, the Medtronic
CoreValve System has been implanted in
more than 15 000 people in more than 40
countries.
‘We are pleased to introduce the
31-mm CoreValve System to expand our
CoreValve portfolio and meet the needs
of more patients in markets where this
lifesaving therapy is approved’, said John
Liddicoat, MD, vice president and gener-
al manager of the Medtronic Structural
Heart Business. ‘The new CoreValve size
may afford many patients with severe
aortic stenosis their first chance at a treat-
ment alternative beyond optimal medical
management or open-heart surgery.’
Emerging markets increasingly
important to Medtronic
Medtronic global CEO Omar Ishrak
noted that Medtronic had achieved a 30%
increase in emerging market revenue, or
25% if reflected at a constant currency
basis. ‘In order to drive growth, Medtronic
will be focused on three key imperatives:
improving execution, optimising innova-
tion and accelerating globalisation’, said
Ishrak. ‘As a company, we need to better
adapt to our changing environment. We
will significantly change the way we
prioritise products in our pipeline, plac-
ing the highest emphasis on our ability
to demonstrate not just clinical value, but
economic value at both the customer and
societal level. Ultimately, our goal is to
use technology to both improve the stand-
ard of care and reduce healthcare costs,
providing greater access to our therapies
for the billions who are currently under-
served. When we do this, we believe
growth will improve’, Ishrak concluded.
Medtronic announces next-
generation pacing system for use
in MRI machines: now available
in Europe
The Advisa DR MRI™ SureScan™ pace-
maker has now been launched in South
Africa and selectedEuropean geographies.
The Advisa DR MRI SureScan pacemak-
er is the company’s second-generation
pacemaker in a portfolio of devices from
Medtronic, designed, tested and approved
for use as labelled with MRI machines in
selected European geographies. Patients
with theAdvisa DRMRI SureScan pacing
system will now have access to full-body
scans without positioning limitations in
the MRI scanner. The Advisa DR MRI
SureScan pacing system is currently
not yet approved for sale in the USA.
‘Half of theworld’s implantedpacemak-
ers are from Medtronic, and the number-
one unmet need is MRI compatibility’,
said Pat Mackin, president of the Cardiac
Rhythm Disease Management business
and senior vice president at Medtronic.
‘We are pleased to now offer physicans
a choice from the world’s first and only
portfolio of MRI-compatible devices for
patients who may need access to the criti-
cal diagnostics available through MRI.’
Remote care of patients with ICD
The REMOTE follow-up of patients with
ICDs appears to be safe, and a large
French trial found no significant differ-
ence in outcome between patients who
were tele-monitored and those who had
conventional check ups in the clinic.
However, the trial failed to confirm the
non-inferiority of the new technology.
Presenting results from the Evaluation
of Tele-follow up (EVATEL) trial at the
recent hot-line session, Prof Philleppe
Mabo from the University Hospital of
Rennes, France, said: ‘The remote follow
up of patients implanted with an ICD
seems to be a safe alternative to conven-
